The present invention relates to manufacturing of a hearing aid housing that is individually matched to the shape of the auditory canal of a user.
In U.S. Pat. No. 5,487,012, a method is disclosed for manufacturing of a hearing aid housing comprising a hearing aid shell with an opening, and a face plate for covering the opening. The shell is individually matched to the shape of the auditory canal of a user. The method comprises the steps of a) direct or indirect acquisition of the shape of the auditory canal to obtain digital data representing the shape, b) conversion of the digital representation of the shape into a multi-dimensional computer model of the outer shape of the matching shell, and c) computer controlled production of the shell based on the data obtained from the three-dimensional computer model of the shell.
Problems relating to manufacture of the face plate are not recognized in U.S. Pat. No. 5,487,012.
It is an object of the present invention to provide further improvements of the above-mentioned method for manufacturing of a hearing aid housing, e.g. improvements related to automation of the manufacture of the face plate.
Thus, it is an object of the present invention to further automate production of individually matched housings of in-the-ear hearing aids.
It is another object of the present invention to facilitate optimum utilization of the space available in the auditory canal and in the outer ear thereby minimizing the size of the hearing aid.
It is a further object of the present invention to provide a hearing aid with a cosmetic attractive appearance.
According to the present invention, the above-mentioned and other objects are fulfilled by a system and a method wherein a) the shape of the auditory canal is acquired and represented by digital data, b) the digital data are converted to a three dimensional computer model of a hearing aid shell that is matched to the shape of the auditory canal, c) positions and shapes of various features of the hearing aid housing, such as junction contour, i.e. the contour of the junction between shell and face plate, vent channel openings, sound input and output openings, battery opening, stubs, bushings, etc, are selected and models of the respective features are included in the shell model, d) a model of a face plate having engaging means for receiving and holding a hearing aid component and mating the shell model is formed and combined with the shell model to form a hearing aid housing model, and wherein e) computer controlled production of a hearing aid housing including the face plate is performed based on the housing model.
Thus, according to the invention manufacturing of the face plate includes at least one automatic processing step based on data from the model of the hearing aid housing whereby the face plate is automatically manufactured to fit the hearing aid shell. For example, junction contour data may be provided to a numerically controlled machine that automatically cuts a separately manufactured face plate along a contour that matches the junction contour.
Various methods of determining or acquiring the shape of a body, such as an ear impression, are well-known in the art. Determination of position of a point on a surface of an object may be performed by moving a mechanical device into contact with the point and reading the position of the mechanical device, e.g. using a co-ordinate measuring machine having scales on moving parts.
In non-contact measurements, positions of points on the surface of an object may be determined by transmitting one or more beams of radiated energy towards the object and detecting radiated energy that has interacted with arbitrary parts of the object.
The radiated energy may be of any form, such as ultrasound radiation, sound radiation, electromagnetic radiation of any frequency, such as radiation of X-rays, gamma rays, ultraviolet light, visible light, infrared light, far infrared radiation, UHF radiation, HF radiation, etc, particle radiation, such as radiation of electrons, neutrons, alpha-particles, etc, etc.
The object, the shape of which is to be determined, may interact with the radiated energy by reflecting, refracting, diffracting or absorbing energy or by any combination hereof.
For example, a laser may emit a linear light beam towards the object under measurement, and a video camera with a CCD chip may be utilized to detect light diffusely reflected from the surface of the object. Then, positions of points of the surface of the object reflecting the light beam are determined by triangulation methods. The beam is swept across the surface of the object e.g. by a movable mirror.
The shape of an object may also be determined with a plurality of electronic cameras. The object is then illuminated by a set of incoherent light sources, such as light bulbs, emitting substantially white light in all directions. A plurality of cameras with known positions in relation to each other are used to determine positions of points of the surfaces of the object by triangulation methods.
When the shape of the auditory canal is acquired by scanning of the canal itself, dynamic recording of the auditory canal may be performed. Since the shape of the auditory canal changes as a result of speaking, eating, drinking etc, this method of acquiring the shape of the auditory canal provides data which vary in time whereby such shape changes can also be taken into consideration during manufacture of the corresponding hearing aid housing.
Alternatively, a plurality of impressions may be made of the auditory canal with the jaw in various respective positions in order to accommodate shape changes of the auditory canal. For example, two impressions may be made namely one with closed mouth and one with open mouth.
Having acquired digital data representing the shape of the auditory canal and a part of the outer ear, these data may be further manipulated according to well-known methods of CAD/CAM systems to design and produce a hearing aid housing, e.g. including forming a three-dimensional model of the shape of the hearing aid shell. Further, the model may be displayed on a computer screen in various three-dimensional views and two-dimensional cross-sections, and various automatic and operator controlled functions, including the functions described herein, for adjustment of the model may be provided by a CAD/CAM system.
Thus, according to the present invention, a CAD/CAM system is provided for design and manufacture of a hearing aid housing with a face plate and a shell that is matched to the auditory canal of a user, comprising a processor that is adapted to receive and process data representing the shape of the auditory canal, forming a three-dimensional model of the shell based on the data, and outputting data representing the model for production of the shell and the face plate based on the model.
Two identical models may be formed from the acquired digital data, i.e. a model of the auditory canal including a part of the outer ear, and a model of the hearing aid shell. The model of the auditory canal remains unchanged while the model of the hearing aid shell may be subject to modifications and additions of various features as will be described below. The models may be displayed in distinguishable colors, and the shell may be displayed inserted in the auditory canal. For this and other purposes, the model of the auditory canal may be displayed transparently.
Upon formation of the three-dimensional model of the hearing aid shell, a contour encircling the shell may be selected for definition of a junction between the hearing aid shell and the face plate, and data representing the selected junction contour may be determined. Preferably, the junction contour is a plane contour.
According to the invention, the shell is produced based on the model and may be terminated with an outward opening defined by the junction contour.
In one embodiment of the invention the junction contour data are transferred to a numerically controlled machine that automatically cuts a separately manufactured face plate along a contour that matches the junction contour. As mentioned above, the junction contour may be a plane contour compatible with a plane face plate.
The face plate may comprise positioning means for engaging with corresponding positioning means of the shell so that the circumference of the face plate matches the junction contour of the shell when the face plate positioning means engage with the shell positioning means.
In a preferred embodiment, the face plate positioning means comprise at least one face plate protrusion at the inner surface of the face plate, and the shell positioning means comprise indentations that are adapted to receive and match the at least one face plate protrusion. The face plate is cut along the junction contour so that it matches the junction contour when the at least one face plate protrusion are received by the mating indentations of the shell whereby correct assembly of the face plate and the shell is facilitated.
In another embodiment, the face plate positioning means comprise at least one face plate protrusion at the inner surface of the face plate terminating at the circumference of the face plate at a distance from the circumference that is substantially equal to the thickness of the shell at the junction contour. The shell positioning means comprise the shell at the junction contour. The face plate is cut along the junction contour so that it matches the junction contour when the ends of the at least one face plate protrusion abut the corresponding part of the inner surface of the shell. The shell positioning means may further comprise protrusions at the junction contour extending inwardly towards the interior of the shell for reception and holding corresponding face plate protrusions.
Shape, dimensions, and position of a battery opening in the face plate facilitating insertion and removal of a battery may be selected and included in the face plate model. Based on the model, the opening may be provided automatically during production utilizing a numerically controlled working machine.
In a similar way, at least one microphone opening may be provided in the face plate.
In another embodiment of the present invention, the hearing aid housing is manufactured with an integrated face plate.
The integrated face plate is defined as a part of the surface of the hearing aid housing that does not match the shape of the auditory canal of the user; rather, it defines a termination of the hearing aid housing facing the surroundings of the user when the hearing aid housing is inserted in the auditory canal.
Obviously, the face plate is integrated when at least a part of the face plate and the shell are produced together as one unit. For example, the face plate is said to be integrated when the joining of the face plate to the shell along the junction contour is produced together with the shell, i.e. during production of the shell the joining of the face plate to the shell is inherently performed.
According to a preferred embodiment of the invention, a three-dimensional model of the face plate is formed that matches the selected junction contour, and the face plate model and the shell model are combined into one three-dimensional model of the hearing aid housing. Based on the combined model, a hearing aid housing with an integrated face plate is produced, e.g. utilizing a rapid prototyping technique, such as stereolithography, laser sintering, fused deposition modeling, drop deposition printing (resembles ink jet printing), etc.
As mentioned above for the non-integrated face plate, shape, dimensions, and position of an opening in the integrated face plate facilitating insertion and removal of a battery may be selected and included in the face plate model that is further included in the housing model.
In a similar way, at least one microphone opening may be provided in the integrated face plate.
Directional characteristics of two microphones positioned at a first and a second microphone opening, respectively, of the at least on microphone openings may be calculated, and first and second positions of the respective first and second microphone openings may be selected that correspond to a desired directional characteristic. The calculations may include the shape of the outer ear, e.g. as determined during determination of the shape of the corresponding auditory canal.
The face plate may have engaging means for receiving and holding a hearing aid component, and a model of the engaging means may be included in the face plate model that in turn is included in the hearing aid housing model so that the integrated face plate may be manufactured with the engaging means, e.g. using a rapid prototyping technique.
In one embodiment of the invention, a face plate is separately manufactured including a battery opening. The separately manufactured plate may also comprise the engaging means. Then, the shell of the hearing aid housing is produced attached to or abutting the plate, e.g. using a rapid prototyping technique, layer by layer, the first layer or cross-section of the shell surrounding the battery opening along the previously selected junction contour of the hearing aid housing.
In another embodiment of the invention, only a part of the face plate including the battery opening is separately manufactured. The circumference of the part is included in the hearing aid housing model, and the hearing aid housing is produced with an integrated face plate attached to or abutting the separately manufactured part layer by layer, the first layer abutting the circumference of the part. Alternatively, the shell may be formed starting with the end opposing the face plate and when the integrated face plate has been formed terminating with an opening having a circumference matching the circumference of the separately produced part of the face plate, the part is positioned in the opening and fitted and attached to the opening.
Further, one or more hearing aid housings may be manufactured in parallel in a batch utilizing rapid prototyping techniques. For example, a batch plate may be separately manufactured including a plurality of battery openings corresponding to a plurality of hearing aid housings. The batch plate may also comprise engaging means of the hearing aid housings. Then, at each of the battery openings a shell is formed, the first layer surrounding the respective battery opening along the junction contour of the respective hearing aid housing. In another example, a plurality of the above-mentioned separately manufactured part of the face plate are positioned in a rapid prototyping apparatus for parallel manufacture of a plurality of hearing aid housings in a batch. A fixture may be provided in the prototyping apparatus with positioning means for accurately receiving and holding the parts in precisely known positions. Each of the parts may be provided with corresponding positioning means that match the positioning means of the fixture.
The separately manufactured face plate or part of the face plate or batch plate may contain parts of metal, such as springs, elastically resilient lugs, electrical terminals, etc.
The hearing aid may be a modular hearing aid comprising a hearing aid housing and an electronic module with a socket, at least one microphone, a signal processor, and a receiver enclosed in the hearing aid housing. The hearing aid housing comprises a face plate having a battery opening defined therein for passage of a battery and the electronic module. Further, the hearing aid housing comprises engaging means for receiving and removably holding the socket. It is an important advantage of the modular hearing aid that the electronic module may be removed from the hearing aid without damaging the hearing aid housing.
The engaging means may comprise grooves, tracks and/or notches for engagement with co-operating socket engaging means formed on the socket.
The socket engaging means may comprise elastically resilient lugs.
The lugs may be integrated with battery terminals projecting from the socket.
Shape, dimension, and position of an acoustic output opening in the hearing aid shell for transmission of sound from the hearing aid towards the tympanic membrane may be selected and included in the shell model.
Displaying the model of the hearing aid housing inserted in the auditory canal model may facilitate selection of a position of the acoustic output opening so that the output opening emits sound in the direction of a longitudinal axis of the auditory canal thus, minimizing the risk of the output opening emitting sound towards a wall of the auditory canal or even being partially or entirely occluded by an auditory canal wall.
Preferably, the hearing aid housing is produced with an integrated ventilation channel. Upon formation of a three-dimensional model of the hearing aid housing, the model including or excluding the face plate, a path may be selected along which the ventilation channel is intended to extend. The ventilation channel may constitute a tube with a uniform or non-uniform cross-section along the length of the channel. The cross-section of the ventilation channel may be of any form, such as a circular, square, rectangular, rectangular with round corners, etc. The shape and dimensions of the ventilation channel cross-section and of the ventilation channel walls may be specified manually, e.g. as is well-known from CAD/CAM systems, and may vary along the length of the channel. The shell wall may constitute a part of the wall of the ventilation channel. Data representing the opening of the ventilation channel in the hearing aid shell opposite the face plate are calculated, and the shell may be automatically produced with the ventilation channel opening. Further, the position and the geometry of the ventilation channel opening in the face plate may be automatically calculated facilitating automatic production of the face plate with the ventilation channel opening.
As for the acoustic output opening, displaying the model of the hearing aid housing inserted in the auditory canal model may facilitate selection of a position of the shell ventilation channel opening so that it points in the direction of a longitudinal axis of the auditory canal thus, minimizing the risk of the ventilation channel output opening being partially or entirely occluded by an auditory canal wall.
Either or both of the acoustic output opening and the ventilation channel opening may be adapted to receive and hold an ear wax guard. The openings and the ear wax guard may be of the types disclosed in WO 00/03561. A pipe stub may be formed in the produced shell extending inwardly in the shell and forming a bushing for insertion of the ear wax guard. A recess may be formed in the shell covering an area around the opening and matching a collar of the ear wax guard or, matching a collar of a bushing to be inserted in the opening for receiving and holding the ear wax guard. Preferably, wall thickness is maintained at the recess to avoid formation of a weak area of the shell.
The shell may be produced with a means for vibration absorbing suspension of the receiver. For example, the shell may comprise strap holders for receiving and holding resilient straps that in turn hold or clutch the receiver providing vibration absorbing suspension of the receiver. In another embodiment, the shell comprises a chamber or protrusions for receiving and holding the receiver, and at least one resilient band fixed around the receiver and having protrusions for supporting and suspending the receiver in the chamber.
The outer dimensions of the hearing aid shell model may be selectively increased so that the corresponding hearing aid shell exerts a pressure on the auditory canal tissue when the shell is inserted in the auditory canal. The outer dimensions may be uniformly increased over the entire surface of the shell, or the size increase may be reduced gradually along a longitudinal axis of the shell so that very little or no pressure is exerted on tissue residing deeply in the auditory canal. Alternatively or additionally, the outer dimensions may be increased at selected areas of the shell surface, e.g. forming a rib partly or fully encircling the hearing aid shell, the rib providing a tight seal against the auditory canal wall when the shell is inserted in the auditory canal.
Further, a tightening contour may be selected that extends along the surface of the shell and partly or fully encircles the shell. A groove extending along the contour may be included in the model having a cross-section with a shape and dimensions that match a desired tightening ring to be mounted in the produced shell, or alternatively, that is adapted for automatic deposition of a material different from the material of the shell, the deposited material constituting a tightening protrusion. The tightening protrusion or the tightening ring provides an appropriate and secure tightening of the shell to the auditory canal when the shell is mounted in the auditory canal. If the hearing aid does not provide a good seal when inserted in the auditory canal, feedback generating oscillations usually occurs and the gain has to be decreased and thus, the full capabilities of the hearing aid can not be utilized. Further, the shape of the auditory canal typically changes in response to user activity, such as chewing, yawning, etc. A rigid hearing aid shell may not be capable of adjusting to changes in auditory canal shape due to movements of the jaw and thus, a shell that is perfectly fitted initially may produce unsatisfactory results in normal use. A flexible tightening ring solves this problem.
In an embodiment wherein the shape of the auditory canal has been determined dynamically, the tightening contour is preferably selected at positions corresponding to positions in the auditory canal at which the above-mentioned dynamic variations of the dimensions of the auditory canal exhibit small variations whereby a secure and tight mounting of the shell in the auditory canal is provided independent of user activity.
Three-dimensional models of shapes and geometries of various hearing aid components, such as microphones, signal processors, output transducers, etc, may be stored in a database, and may be selected for incorporation into the hearing aid. Utilizing well-known CAD/CAM methods, models of the selected components may be positioned and displayed within the hearing aid housing model and may be moved around for selection of respective optimum positions and orientations, e.g. for provision of a hearing aid of a minimum size. Collision checks may be performed, and positions of the features of the hearing aid shell, e.g. the vent channel, may also be moved around to further optimize positioning of the hearing aid components.
Although there may be sufficient room for a specific component at a certain position within the shell, it may not be possible to move the component into that position, e.g. because the internal volume of the shell forms a bottle neck at the input opening. Thus, during design of the hearing aid, collision check may also be performed during movement of the component in question through the input opening into the shell along a desired path towards the desired mounting position.
The shape of the shell may be adjusted selectively in order to increase the internal volume of the shell for provision of sufficient space for a specific component. Preferably, the outer volume of the shell is increased at areas corresponding to ear locations that are relatively non-sensitive to pressure.
The selection of the path of the junction contour may be performed while the shell model is displayed as inserted in the auditory canal. In this way, the position of the face plate covering the shell outward opening may be selected for optimum cosmetic appearance when the hearing aid is inserted in the auditory canal. It should be noted that a model of a part of the outer ear should be included in the model of auditory canal facilitating evaluation of the cosmetic appearance of the hearing aid. Typically, an impression of an auditory canal also contains an impression of a part of the outer ear.
The surface of the shell model may be smoothed to eliminate sharp edges and corners and to obtain a smooth surface. The entire shell may be smoothed or specific areas of the shell may be selected, e.g. using a computer mouse with a cursor, for smoothing by well known CAD/CAM smoothing techniques.
For example, presence of cerumen or fall off tissue in the auditory canal when the impression of the auditory canal is made may create undesired artifacts in the shell model. An artifact may be removed from the hearing aid housing model by deleting the surface covered by the artifact from the model and calculating a new surface substituting the deleted surface based on the model surface surrounding the artifact.
Further, a serial number or another identification of the produced hearing aid housing may be incorporated into the housing model, e.g. in a selected position, so that the housing may be produced with an inherent identification.
The finished hearing aid housing model may be stored in a database for later retrieval.
The database may be utilized for further automation of the design process. For example, the acquired data representing the shape of an auditory canal may be compared to the shape of housing models stored in the data base, and the best match may be retrieved and the positions of features of the hearing aid housing and selections, positions, and orientations of hearing aid components may automatically be reused in the hearing aid housing to be designed. An operator may subsequently adjust or change the retrieved positions, orientations and selections. The comparison may be performed solely for selected corresponding areas of the hearing aid housings. The models may be stored in the database in a reduced form requiring a reduced amount of data, since the very high mechanical tolerances required for production of hearing aid housings are not required for comparisons of shape with the purpose of reusing positions, orientations, selections, features, or components relating to the stored hearing aid housing models.
A patient database may be formed comprising records with a patient identifier, e.g. name and number, holding the hearing aid housing model of the patient in question. The records may further hold respective models of the original impression of the auditory canal of the patient, and identifiers and models of the hearing aid components used in the patient""s hearing aid, etc. A new hearing aid for a specific user may then be produced without having to acquire the shape of the auditory canal again, e.g. by making a new impression of the auditory canal, since the previously acquired shapes may be easily retrieved from the patient database.
It is well-known in the art to produce a housing based on a three-dimensional computer model of the housing utilizing so-called rapid prototyping techniques, such as stereolithography, laser sintering, fused deposition modeling, drop deposition printing, etc.
For example, in stereolithography, the computer model is converted into a number of cross-sections that may be equidistant, plane-parallel and horizontal, but need not be. Then, the housing is manufactured by producing the individual cross-sectional planes successively and on top of each other, underneath each other or next to each other and joining them together. A container with activated liquid synthetic resin may be located on a computer controlled movable platform. By targeted use of radiation directed at the surface of the liquid synthetic resin and causing at least part-polymerization of the synthetic resin, it is possible to generate a first cross-section of the hearing aid housing. After completion of each cross-section, the platform is lowered by the layer thickness so that the next cross-sectional plane on the surface of the liquid synthetic resin can be produced in the same way. This continues until the polymerized housing can be removed from the container.
Laser sintering is another layered fabrication process producing a three-dimensional object from powdered materials in a layered fashion utilizing heat generated by a CO2 laser. As in stereolithography, the computer model is converted into a number of cross-sections successively produced by applying the laser beam to a thin layer of powder. The laser beam fuses the powder particles to form a thin layer of solid mass. The laser sintering process allows for the use of a variety of powdered materials.
A further possibility is to produce the cross-sections with a printing method similar to that used in an ink-jet printer, i.e. a drop deposition printing, for example, by consecutively producing successive cross-sections using the drop depositioning printing and, after at least partial polymerization which should already take place at the printing operation, by then stacking them on top of each other and joining them to form a shell.
It is an important advantage of the present invention that a hearing aid housing that is matched to a specific auditory canal and that includes various features, e.g. an integrated face plate, a ventilation channel, a tightening protrusion, a battery opening with engaging means, an ear wax guard holder, etc, can be produced automatically with a minimum of manual operations.
Preferably, the shell is produced from a flexible, sweat resistant material. The material should not cause allergic reactions.
The shells are preferably polished in a polishing cylinder.
The material may be colorless or may be of a color that is close to a desired color. Then, the shell may be colored in a coloring substance of a desired color, e.g. by dipping the shell in the coloring substance.